BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHOLL FREEZE VERRUCA AND WART REMOVER

    MDR report key: 3880586 · Received April 9, 2014

    Report

    Report Number
    3004142665-2014-00002
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACKAGE INSTRUCTIONS WARN THAT THE PRODUCT IS EXTREMELY FLAMMABLE. IT FURTHER STATES, "KEEP AWAY FROM SOURCES OF IGNITION - NO SMOKING." (B)(4) IS CURRENTLY ATTEMPTING TO OBTAIN THE IMPLICATED PRODUCT. A FOLLOW-UP WILL BE SUBMITTED AFTER THE PRODUCT EVALUATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HIS SCHOLL VERRUCA AND WART REMOVER BLEW UP, WHICH HE THEN DROPPED ON THE FLOOR AND SUBSEQUENTLY BURNT HIS CARPET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213346 SCHOLL FREEZE VERRUCA AND WART REMOVER UNK GEH ORASURE TECHNOLOGIES, INC. 1001-0166

    Patients

    Seq Age Sex Outcome Treatment
    1